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Conditions of Diagnostic Panendoscopy of the Upper Airway Under Propofol Remifentanil General Anesthesia

Information source: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Tumor of Ear, Nose and Throat

Intervention: Remifentanil (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Centre Hospitalier Universitaire de Besancon

Official(s) and/or principal investigator(s):
Sébastien Pili Floury, MD , PhD, Principal Investigator, Affiliation: CHRU Besançon
Angéline Chopard-Guillemin, MD, Principal Investigator, Affiliation: CHRU Besançon
Amélie Jurine, MD, Principal Investigator, Affiliation: CHRU Besançon
Guillaume Besch, MD, Principal Investigator, Affiliation: CHRU Besançon
Arnaud Causeret, MD, Principal Investigator, Affiliation: CHRU Besançon

Summary

The most important considerations for the general anesthesia in diagnostic panendoscopy of the upper airway is the maintenance of a patient's airway for optimal surgical exposure, adequate ventilation and sufficient depth of anesthesia. Tubeless anesthestic techniques with preserved spontaneous ventilation and total intravenous administration of anesthetic drugs are widely use. Due to its pharmacological profile, propofol anesthesia is often considered as the gold standard for the anesthesia in the diagnostic panendoscopy. Previous studies suggested that adding remifentanil to propofol could improve the conditions for laryngoscopy and tracheal intubation. The aim of this study is to assess the impact of propofol remifentanil general anesthesia compared to propofol general anesthesia on the conditions of the diagnostic panendoscopy of the upper airway.

Clinical Details

Official title: Evaluation of the Impact of Adding Remifentanil to Propofol on the Conditions of the Diagnostic Panendoscopy of the Upper Airway Under General Anesthesia With Tubeless Spontaneous Ventilation.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Primary outcome: Proportion of patients presenting clinically acceptable conditions for the diagnostic panendoscopy of the upper airway

Secondary outcome:

DeltaHRmax

DeltaHRmin

DeltaMAPmin

DeltaMAPmax

Proportion of patients presenting at least one episode of moderate hypoxemia

Proportion of patients presenting at least one episode of severe hypoxemia

Proportion of patients requiring invasive mechanical ventilation

Proportion of patients presenting surgery complications

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Elective diagnostic panendoscopy of the upper airway

- Age > 18 and < 80 years old

- American Society of Anesthesiology (ASA) score equal to 1, 2, or 3 with a stable

condition

- Written inform consent

Exclusion Criteria:

- Pregnancy or breastfeeding

- Age < 18 years old or inability to give informed consent

- Known anaphylaxis to remifentanil or propofol

- Long term opioid use, drug abuse

- Predictive criterion of impossible mask ventilation or intubation

- Chronic respiratory failure requiring oxygen therapy

Locations and Contacts

Centre Hospitalier Régional Universitaire, Besançon 25000, France

CHRU Besançon, Besançon 25000, France

Additional Information

Related publications:

Schnider TW, Minto CF, Gambus PL, Andresen C, Goodale DB, Shafer SL, Youngs EJ. The influence of method of administration and covariates on the pharmacokinetics of propofol in adult volunteers. Anesthesiology. 1998 May;88(5):1170-82.

Minto CF, Schnider TW, Egan TD, Youngs E, Lemmens HJ, Gambus PL, Billard V, Hoke JF, Moore KH, Hermann DJ, Muir KT, Mandema JW, Shafer SL. Influence of age and gender on the pharmacokinetics and pharmacodynamics of remifentanil. I. Model development. Anesthesiology. 1997 Jan;86(1):10-23.

Minto CF, Schnider TW, Shafer SL. Pharmacokinetics and pharmacodynamics of remifentanil. II. Model application. Anesthesiology. 1997 Jan;86(1):24-33.

Starting date: June 2009
Last updated: March 19, 2014

Page last updated: August 23, 2015

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